- LOGIN
- MemberShip
- 2026-07-01 12:03:09
- Product
- There are about 2,300 pharmacies dedicated to COVID-19
- by Jung, Heung-Jun Aug 24, 2022 05:55am
- Increase in active prescription recommendations of the Korea Medical Association, and short expiration date also affects prescription volume. The number of pharmacies in charge of COVID-19 treatments has more than doubled in a month. The number of pharmacies in charge increased from 996 on the 11th of last month to 2,314 on the 19th of this month. The number of participating pharmacies has increased, but the number of treatment preparations per pharmacy has not decreased. This is because the number of confirmed patients has increased and the number of prescription lawmakers has increased. The number of prescription preparations is expected to increase further in the future as the Korea Medical Association actively recommended prescriptions last week. Pharmacy A in Seoul said, "On average, there are 30 prescriptions a day, and when there are a lot, there are up to 50 prescriptions. It is mainly focused on Paxlovid, and Lagevrio is also on the rise in prescriptions. "We have room for government inventory, so we are properly secured when we are aware of it and when it is insufficient," the pharmacist said. Pharmacy A said, "As the number of clinics to prescribe treatments increased, nearby pharmacies applied for participation and the number of base pharmacies increased. It will be distributed to new pharmacies, but the increase in the number of prescriptions shows that the total number of prescriptions has increased." Until now, the amount of prescriptions for treatments has varied by region, but recently, the number of treatments has also been increasing in areas where demand for treatments has been low. Pharmacy B in Seoul said, "In our region, there were few prescriptions. It was about one to two cases a day, but recently it has increased to five to six cases, he said. "We are prescribing at a clinic located in apartment complex , and patients are visiting and receiving prescriptions." In our region, pharmacies have been designated more than twice, and the number of prescriptions is increasing as lawmakers actively prescribe them," he said. Pharmacists analyzed not only the severe prevention of COVID-19 confirmed patients, but also the short expiration date of the treatment as a reason for encouraging prescription. It is explained that the number of patients is increasing after the Korea Medical Association's recommendation for prescription. "The number of newly designated pharmacies in our district has increased as much as existing pharmacies," said the pharmacy in charge of C in Seoul. However, the number of preparations has increased a lot, and about 15 to 20 cases are received per day. The large number of elderly patients in the region is also the reason for the large number of prescriptions. Pharmacy C said, "The Korea Medical Association encourages prescriptions and feels the increase. The expiration date of the treatment is short, but it seems that there is an intention to prescribe it to patients who need it within the deadline, the pharmacist said.
- Policy
- Na Kyung-won is considering being the Minister of Health
- by Lee, Jeong-Hwan Aug 23, 2022 06:04am
- The opposition party is immediately criticizing the new government as Yoon Seok-yeol's office is reportedly considering Na Kyung-won, a former lawmaker with four-term experience, as a candidate for the next health and welfare minister. According to political circles of the ruling and opposition parties on the 22nd, President Yoon Seok-yeol put former lawmaker Na on the list of candidates for the welfare minister, which was compressed three times. She is said to have experience in related fields by working at the National Assembly's Health and Welfare Committee in the past and has experience and expertise in the field of health and welfare, including an honorary doctorate in social welfare at Soonchunhyang University in July. Having political power, such as serving as the floor leader of the Liberty Korea Party, the predecessor of the people's power, is also cited as the reason why former lawmaker Na is considered as the minister of welfare. Former lawmaker Na herself shows a cautious position or denies it. Regarding the appointment of the minister, former lawmaker Na is repeatedly answering in media interviews, saying, "There was no such thing at all," "There was no communication with the president's office," and "I didn't hear it." In response to this situation, politicians are speculating that it is a roundabout way of expressing their position to challenge the leadership of the people. She was recently mentioned as a strong candidate for the next party leader and said she was considering whether to challenge for the party's leadership. Na has recently been leading in several polls related to party leadership of the party. Lee Soo-jin, floor spokesman of the Democratic Party of Korea, said, "The appointment of Yoon Seok-yeol should signal a personnel reshuffle, not an extension of the personnel disaster," adding, "President Yoon is reportedly considering former lawmaker Na Kyung-won as a candidate for the welfare minister." "It is disastrous to consider a person who ran as a candidate for Seoul mayor in the 2011 local elections and was criticized for bathing teenagers in front of reporters as welfare minister," she pointed out. "President Yoon said at a 100-day press conference that the most important thing in the management of state affairs is the will of the people first and second," spokesman Lee Soo-jin said. "All policies, people, and attitudes should be changed." It is the will of the people to reform personnel and completely change the stance of state administration," she said.
- Policy
- Bill for 'state compensation for Paxlovid's side effects'
- by Lee, Jeong-Hwan Aug 23, 2022 06:04am
- A bill proposing the government's compensation for damages arising from the administration of COVID-19 treatments that were granted Emergency Use Authorization (EUA) such as Paxlovid or Lagevrio etc. has been filed. On the 22nd, People Power Party member Mi-Ae Kim proposed a bill as representative for the partial revision of the “Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis” which contained the abovementioned contents. Currently, side effects arising from COVID-19 vaccines are compensated based on the ‘Infectious Disease Control and Prevention Act,’ and the side effects arising after administration of drugs that are granted marketing authorization are compensated based on the “Pharmaceutical Affairs Act’ under respective side effect damage relief systems. However, under current laws, no clear grounds existed to provide compensation for side effects arising from the use of oral COVID-19 treatments that were granted EUA. To address this, People Power Party member, lawmaker Miae Kim submitted a bill that allows for the state to compensate for damages occurring due to the use of drugs approved for emergency use and the standards, scope, and procedure for compensation and investigation and appraisal for compensation payment to be applied the Pharmaceutical Affairs Act. As of the 22nd, the Ministry of Food and Drug Safety has granted EUA for 5 COVID-19 treatments – Evusheld inj., Lagevrio cap., Actemra inj., Vekury Powder For Concentrate For Solution For Infusion, and Paxlovid. If the National Assembly passes Kim’s bill, a safety net will be established for the state’s compensation for side effects that arise from the treatments that were granted EUA. In addition, the bill contained a provision to add separate subcommittees for each area of the Public Health Crisis Response Medical Product Safety Management and Supply Committee. It also provided a basis to entrust the maintenance and management of the crisis response medical product information system to the President of the Korea Institute of Drug Safety & Risk Management. Kim said, “We need to protect the lives and safety of our people from the damages and side effects caused by the use of EUA treatments."
- Policy
- When will the CSO reporting system be legislated?
- by Lee, Jeong-Hwan Aug 23, 2022 06:04am
- In consensus, the government and pharmaceutical industry are voicing the need to legislate the pharmaceutical contract sales organization (CSO) reporting system and urging the National Assembly to review the bill. Both the government and pharmaceutical industry share the position that a bill needs to be passed by the National Assembly to accurately identify CSOs that perform drug sales and promotion activities for pharmaceutical companies, such as one-person CSOs, to abolish indirect illegal rebates. On the 21st, the Ministry of Health and Welfare and the pharmaceutical industry were found to be busy closely following the National Assembly’s review and passage of the bill for the establishment of the CSO reporting system. Both the MOHW and industry believe that identifying the status of CSOs that are acting on behalf of domestic pharmaceutical sales is difficult because of the delay in the timely review of the CSO reporting system. In particular, the MOHW is closely eyeing the legislative timeline because the ministry can only publicly announce the standards and guidelines on the eligibility of the CSO reporting system after the bill is passed by the National Assembly. The CSO reporting system is a bill to regulate the CSO's drug promotion activities conducted on behalf of pharmaceutical companies that have not been reported to the government and local governments as illegal. The bill, if legislated, is expected to have a significant impact on the domestic pharmaceutical business environment. The MOHW plans to discuss and finalize the details of the system, such as the subject for the CSO report and the reporting system, with related ministries such as the Ministry of the Interior and Safety as soon as the bill passes NA review and is finalized. The industry has also long been awaiting the legislation of the CSO reporting system. Relevant laws have already been revised and CSOs are subject to filing and submitting expenditure reports. However, as the bill for the CSO reporting system is yet to be passed, the specific size of the CSOs industry is difficult to identify. This is why the criticism that a legal loophole has been created as the subjects for filing and submitting expenditure reports had been expanded, but those subject to the system are not identifiable, leaving open the risk for the rise of illegal indirect rebates. In addition, the bill to legislate the CSO reporting system needs to be passed for the pharmaceutical sales order education to be legislated, and the obligation to write and manage consignment reports be introduced for further reinforcement of the drug distribution order. Also, the passage of the bill will abolish the rebate attempts where some companies pay excessive promotion fees to CSOs for indirect rebates. An official from the Korea Pharmaceutical and Bio-Pharma Manufacturers Association said, “CSOs are being imposed the same level of obligations as pharmaceutical companies in filling out and submitting economic profit expenditure reports but without the passage of the CSO reporting system, which companies will be applied the system, including one-person CSOs cannot be clearly identified. The CSO system will allow the government to clearly identify and distinguish CSOs and assign the duty to prepare and manage consignment reports and prevent indirect rebates.” An official from a pharmaceutical company said, “Also, the system needs to be introduced to solidly establish a distribution order through pharmaceutical sale order education, etc. Currently, there is a widespread perception that CSOs are used as a window for rebates after being paid excessive promotional fees. The legislation is expected to have the effect of preventing excessive competition by allowing the pharmaceutical companies to pay appropriate fees to their CSOs while strengthening the government’s management and supervision function." Meanwhile, the MOHW plans to publicly disclose the expenditure report content submitted by pharmaceutical companies and medical device companies from January 2024 on its webpage and through other public systems. The MOHW and the pharmaceutical industry believe the CSO reporting system needs to be implemented in a timely manner in line with the public disclosure system for the expenditure report.
- Policy
- There is no concern about the disposal of COVID-19 PO tx
- by Lee, Jeong-Hwan Aug 23, 2022 06:03am
- Regarding the criticism that many of the COVID-19 PO treatments held by the quarantine authorities are likely to be discarded due to the expiration date early next year, it expressed that there is no problem in proper inventory management. As the use of PO drugs is increasing due to the re-proliferation of COVID-19 and an active prescription environment has been established, the current reserves can be used until November, so the introduction of additional supplies should be coordinated, not discarded. On the 18th, the KDCA made this announcement at a regular briefing for COVID-19. Some media reported that based on a report by the National Assembly's Budget Office, 700,000 of the 960,000 PO drugs brought in so far, will have to be discarded after the expiration date in February next year. In the briefing, a question was also asked about the criticism that many of the treatments will be discarded in February next year. The KDCA explained that in order to minimize damage to high-risk groups, it expanded hospital prescription institutions, increased pharmacies in charge, and encouraged medical staff to actively prescribe oral drugs. It also said that the current amount of oral drugs is doses for 690,000 people, which can be responded to by November this year, considering the recent weekly usage. The move is aimed at exhausting all of the current holdings before the disposal time in February next year. An official from the KDCA said, "We plan to flexibly adjust the additional introduction of the COVID-19 oral drug as it currently has a quantity that can be responded to by November rather than concerns about disposal." "We are also discussing with related agencies about extending the expiration date of Paxlovid and Lagevrio," he said. The official said, "We will push for proper inventory management without disposal for Paxlovid, which is scheduled to expire in February next year."
- Company
- Omega-3 prescription market doubles in 3 Years
- by Kim, Jin-Gu Aug 23, 2022 06:03am
- KuhnilIt is expected that generic companies will join and fierce competition is expected. The market for Omega-3 is rapidly expanding. The performance of outpatient prescriptions in the first half of the year has more than doubled in three years. The prescription performance of Omega-3 and Statins has increased significantly. It is predicted that competition in this market will become fiercer in the future, centering on the omega-3 and Statin complex. According to UBIST, a pharmaceutical market research firm on the 17th, the size of outpatient prescriptions in the Omega-3 Rx market in the first half of this year is 72 billion won. Compared to the first half of 2019, it has expanded 2.1 times. This market is growing rapidly around 2020. Based on the quarterly prescription amount, it was below 20 billion won until the third quarter of 2019, but it surpassed 20 billion won in the fourth quarter and exceeded 30 billion won in the second quarter of 2021. In the second quarter of this year, it recorded 36.8 billion won, looking at the quarterly prescription amount of 40 billion won. While the Omega-3 single system has steadily expanded its influence, the Omega-3 and statin complex has joined in earnest, driving the market expansion. In fact, the prescription amount of omega-3 and statin composites in the first half of 2019 was only 2.4 billion won, but it increased 5.9 times in three years to 14.3 billion won this year. In July 2017, Kuhnil was approved for Rosumega as the first omega 3+ Rosuvastatin complex. Rosumega paid 600 million won in prescription that year, and increased to 4.1 billion won the following year. After recording 6.7 billion won in 2019, it has become a large item that pays about 10 billion won in prescriptions since 2020. With Rosumega on the market, other generic companies have joined the competition. In December 2020, Jeil, Yuyu, Boryeung, Kyung Dong, Korea Prime, and Futecs were granted generic of the Omega 3·Rosuvastatin complex. These products are manufactured by Kuhnil. Last year, United joined the new competition. Instead of commissioning production to Kuhnil, United challenged Kuhnil head-on through patent raids. United, which won the patent dispute, released Atmeg Combigel Soft Cap in the second quarter of last year as an Omega 3+ Atorvastatin compound. Atmeg Combigel is rapidly expanding its prescription performance with its release. The prescription amount, which was 1.2 billion won in the second quarter of last year, increased seven times to 8.3 billion won in the second quarter of this year. United plans to expand its performance to 20 billion won a year. It is expected to have more intense competition in the future, centering on the Omega-3 and Statin complex. Kuhnil was licensed for combination generics such as Atmeg Combigel, signaling competition. Along with Kuhnil, Daehannupharm, Dongkoo Bio, Hutecs, and Penmix are expected to enter the market. Kuhnil plans to produce their products on consignment. United plan to face Atmeg Combigel with new dosages. In addition to the existing Atorvastatin 10mg + Omega-3 1,000mg product, United has recently received approval for Atorvastatin 5mg + Omega-3 1000mg product. On top of that, it plans to release additional medicines with the same ingredients through its affiliated company Korea Biochem.
- Company
- Abilify 1mg can be prescribed at tertiary hospitals
- by Eo, Yun-Ho Aug 22, 2022 05:53am
- A new 1mg strength formulation of ‘Abilify’ can now be prescribed at general hospitals According to industry sources, Korea Otsuka Pharmaceutical's antipsychotic ‘Abilify (aripiprazole)’ has passed the drug committees (DCs) of major hospitals in Korea, including the Seoul National University Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital. The company has been working to make prompt entry into the market after receiving reimbursement approval for its new strength in March this year. The 2mg, 5mg, 10mg, and 15mg strengths of Abilify have already been approved in the past. The introduction of the 1mg strength is the first change made in the product lineup in 6 years since the company received approval for ‘Abilify Maintena inj.’ In 2015. When narrowing the product line to Abilify tablets alone, this is the first change made in 13 years since 2008 when the 2mg tablet formulation was approved. Although a 1mg strength for Abilify did not exist in the past, prescriptions of the 1mg dose have been frequently made by splitting the 2mg strength tablet. The 1mg dose was used for dose-sensitive first-time patients with neuropsychiatric disorders etc. Whether Abilify may be able to secure its sales in the market that is being challenged by generics by introducing the low-strength formulation remains to be seen. According to the market research institution IQVIA, Korea Otsuka Pharmaceutical's Abilify series makes the most sales among all schizophrenia treatments in Korea. Its 3 products - Abilify tab, Abilify OD tab, and Abilify Maintena inj – had raised ₩50.9 billion in sales in 2020. With the same product line, the company made ₩27.4 billion in the first half of the year last year.
- Policy
- “Bio-vaccine fund will be created within the year”
- by Lee, Jeong-Hwan Aug 22, 2022 05:53am
- President Yoon Suk-Yeol reconfirmed his new government’s plan to raise and create a K-Bio·Vaccine Fund that focuses investments on Phase III trials within the year. The government will induce investments with pan-ministerial support and also accumulate data on 1 million people to develop next-generation treatments such as advanced biopharmaceuticals and precision medicine. Also, a public policy-based fee system will be implemented to reinforce essential healthcare such as less-favored areas such as craniotomy for cerebral aneurysms and areas with reduced demand, such as pediatrics and childbirth. On the 19th, the Ministry of Health and Welfare reported the new government’s operation plan that contained the abovementioned plans to the president. ◆Making the leap to become a global biohealth hub=The MOHW announced plans for Korea to make the leap and become a global biohealth hub. It plans to strengthen pan-ministerial support to attract investment from companies in Korea and abroad and raise and create a K-Bio·Vaccine Fund that focuses on Phase III trial investments within the year to attract private investments. Also, the ministry will provide regulatory relief by reorganizing the innovative medical device designation system within and announcing step-by-step implementation plans to innovate the biohealth regulations within the year. In addition, a ‘National Integrated Bio Big Data’ system will be established to develop next-generation treatments such as advanced biopharmaceuticals and precision medicine. With the goal of accumulating data on 1 million people, the government will apply for a preliminary feasibility study within the year. Also, a ‘Health Information Expressway’ will be created to safely manage and relay personal health and medical data for customized use by HCPs. R&D investments to establish health security and resolve national challenges will also be expanded, with the goal of reaching ₩1 trillion in 2025. In particular, the investment will be concentrated on securing core technologies such as mRNA (messenger ribonucleic acid) platforms, antiviral drugs, and universal vaccines. ◆Advancing capabilities for infectious disease response= The government’s 3rd-year COVID-19 countermeasures were also presented in the report. The plan is to promote precise, targeted quarantine in infection-vulnerable areas while maintaining daily life. Therefore, targeted distancing measures such as restricting visits and prohibiting outdoor visits or stays will be implemented in vulnerable facilities that have a high frequency of confirmed COVID-19 cases. In order to prevent group infection and progression to severe disease in such infection-vulnerable facilities, preemptive tests for workers will be expanded, and confirmed patients will be promptly treated to prevent further infection or disease progression. Also, access to testing will be reinforced by extending weekend and nighttime operation hours of screening centers (602 centers) and temporary screening centers (6 centers). Also, progression to severe disease in high-risk groups such as the elderly will be prevented by utilizing one-stop medical institutions (currently 12 locations) that can test, treat, and prescribe COVID-19 treatments within one day. As of 00:00, the proportion of COVID-19 patients aged 60 years or older among patients with severe·critical disease and deaths were 86.8% (427 patients) and 91.6% (76 patients), respectively. Also, outpatient prescriptions of COVID-19 treatments will be made possible at the patient's regular hospitals with the allowance of outpatient prescriptions in such hospitals and an increased number of pharmacies that handle COVID-19 treatments. A system for intensive treatment of severely ill patients and rapid response to emergency patients will also be prepared. Communication will also be strengthened. Ki-Seok Jeong, Chairman of the National Infectious Disease Crisis Response Advisory Committee, will be appointed Director-General of Special Response Central Disaster and Safety Countermeasure Headquarters, and will be running and explaining COVID-19-related news to the public in easy terms through the YouTube channel, ‘COVID-19 TV.’ Also, communication with the medical community will be strengthened by operating a city-regional medical consultative body with doctors’ associations in cities and provinces. ◆Expanding essential healthcare through introduction of public policy-based fee system, etc. =Also, the government will work to expand essential healthcare through the introduction of a public policy-based fee system and reform of the national health insurance expenditures to prevent the recurrence of tragedies such as the recent death of the nurse at Asan Medical Center. Essential healthcare refers to services that pose a serious threat to the lives of the people if not urgently provided, or are inadequately provide due to reduced medical demand. A public policy-based fee system will be implemented to strengthen the grounds for essential healthcare, in less-favored areas such as craniotomy for cerebral aneurysms and areas with reduced demand such as pediatrics and childbirth. Compensation for high-risk high-difficulty operations and emergency operations that are less frequent but high-risk such as aortic dissection, heart, and brain surgery that are shunned will be strengthened by increasing the policy-based premium fee. Also, support for the recovery of infrastructure on childbirth will be reinforced through measures such as raising fees and support for vulnerable regions. Also, compensation will be reinforced and infrastructure expanded after evaluating essential healthcare to identify areas in deficit such as children's hospitals. The plan also contained measures to increase the listing of essential healthcare and high-priced drugs through a thorough re-evaluation of existing reimbursed items that cause excessive use such as ultrasound and MRI, the improvement of standards for foreign dependents, and preventing theft of health insurance qualifications.
- Company
- Strong performance of overseas subsidiaries of companies
- by Kim, Jin-Gu Aug 22, 2022 05:52am
- Starting from the left, "Beijing Hanmi", "YANGZHOU ILYANG PHARM", "GC China"Daewoong Pharmaceutical's Southeast Asian subsidiary doubled in a year. Major overseas subsidiaries of pharmaceutical bio companies showed strong sales in the first half of last year. Most of the local subsidiaries in China and Southeast Asia showed an increase in sales compared to the same period last year. Beijing Hanmi, Celltrion AP (Asia-Pacific), and Celltrion USA set new sales records based on half-year sales. ◆ Beijing Hanmi records half-year sales According to the Financial Supervisory Service on the 20th, the combined sales of 22 Chinese local subsidiaries of 10 Korean pharmaceutical companies in the first half of the year were 314.8 billion won. It increased 14% compared to 275.4 billion won during the same period last year. Net profit increased 28% from 38.5 billion won in the first half of last year to 49.1 billion won in the first half of this year. Beijing Hanmi broke the previous half-year sales record by making 173.3 billion won in sales in the first half of the year. It increased 30% compared to 132.9 billion won in sales in the first half of last year. Half-year sales of Beijing Hanmi recorded around 120 billion won before COVID-19. In the first half of 2020, when COVID-19 was rampant in China, it plunged to 92.8 billion won. However, after recovering to 110.7 billion won in the second half of 2020, 132.9 billion won in the first half of last year, 155.8 billion won in the second half of this year, and 173.3 billion won in the first half of this year. Beijing Hanmi expanded its syrup factory last year. The operation rate of this plant has been maintained at 100% this year. An official from the U.S. in Beijing explained, "As a result of timely expansion of facilities and supplying products in line with the rapid increase in demand for respiratory patients and cold medicines in China, we achieved solid performance until the first and second quarters." Most of the other Chinese subsidiaries have also grown by a large margin. In the case of Chong Kun Dang, sales at Chong Kun Dang Health in Qingdao more than tripled from 1.1 billion won to 6.7 billion won. Guangdong Pharmaceutical's total sales in the first half of the year were 20.1 billion won, up 24% from the same period last year. Daewoong Pharmaceutical has four subsidiaries in China, including Sacheon Daewoong Biotechnology Limited, Liaoning Daewoong Pharmaceutical Limited, and Beijing Daewoong Pharmaceutical and Technology Limited. The combined sales of the four corporations increased 39% from 8.8 billion won to 12.3 billion won in a year. YANGZHOU ILYANG PHARM·TONGHUA ILYANG HEALTH PRODUCTS of Ilyang Pharmaceutical recorded 71.2 billion won in sales in the first half of the year. It increased by 5% compared to 67.7 billion won in the first half of last year. Among major Chinese subsidiaries, sales of GC Pharma's subsidiaries declined. Total sales of GC China and GC China Pharm fell 34% year-on-year to 29.8 billion won. ◆ Celltrion and Takeda products in earnest in the Asia-Pacific region, Diagnostic kits are booming in the U.S Local subsidiaries in Southeast Asia also performed well in the first half of the year. Particularly noticeable is Celltrion's Celltrion Asia Pacific PTE located in Singapore. It recorded 75 billion won in sales in the first half of this year. It nearly tripled from 25.2 billion won in the first half of last year. Net profit also shifted from a deficit of 6.8 billion won to a surplus of 9.7 billion won. Analysts say that the sale of 18 products acquired from Takeda Pharmaceutical has begun in earnest. Celltrion Pharmaceutical is in charge of sales in Korea, and Celltrion Asia Pacific PTE is in charge of sales in the remaining eight countries, including Thailand, Taiwan, Hong Kong, Macau, the Philippines, Singapore, Malaysia, and Australia. In the case of Daewoong Pharmaceutical, the total sales of five local subsidiaries located in Thailand, Indonesia, and the Philippines more than doubled from 8.4 billion won to 17.2 billion won. In the case of Chong Kun Dang, sales of local subsidiaries in Indonesia increased 2.2 times from 2.1 billion won to 4.7 billion won in a year. In addition, in the North American market, Celltrion USA made strides by increasing its sales nearly 16 times in a year. Celltrion USA's sales in the first half of this year increased from 9.4 billion won last year to 150.4 billion won in the first half of this year. Celltrion USA's sales expansion is attributed to strong sales of COVID-19 diagnostic kits. Celltrion is jointly developing and selling antibody diagnostic kits, antigen rapid diagnostic kits, antigen home test diagnostic kits, and neutralization antibody diagnostic kits with Humasis. Among them, antigen rapid diagnostic kits and antigen home test diagnostic kits have been supplied to the U.S. in earnest since late last year through Celltrion USA.
- Company
- Avastin biosimilar Vegzelma has obtained a European license
- by Kim, Jin-Gu Aug 22, 2022 05:52am
- Celltrion announced on the 19th that Vegzelma (CT-P16) developed with Avastin biosimilar has obtained a sales license from EC on the 18th (local time). According to Celltrion, Vegzelma received an EMA approval recommendation in June. Within two months after that, it received permission to sell full labels approved by Avastin, including metastatic direct bowel cancer and non-small cell lung cancer. Celltrion's strategy is to quickly settle Vegzelma in the market with cost competitiveness by mobilizing all of its own drug development and production capabilities. Celltrion has also completed a global patent agreement with the original drug developer before obtaining Vegzelma's permission, and plans to release it in Europe through Celltrion Healthcare within this year. Vegzelma is the third anticancer antibody biosimilar developed by Celltrion after blood cancer treatment Truxima and breast cancer and stomach cancer treatment Herzuma. Celltrion expects Vegzelma's sales license in Europe to further strengthen its anti-cancer drug portfolio. Celltrion is revealing the possibility of Vegzelma's permission in the U.S. and Korean markets following Europe. Celltrion also applied for Vegzelma's sales license to the Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA) at the end of last year, and expects approval within the year. According to IQVIA, a global pharmaceutical market research firm, the global Bevacizumab market in 2021 is $6.413 billion, of which the European market accounts for $1.614 billion and the U.S. market accounts for $2.62 billion. A Celltrion official said, "With Vegzelma's permission to sell in Europe, Celltrion has secured its third anticancer antibody biosimilar." He said, "We will do our best to help Vegzelma settle in the European biosimilar market early and proceed with the remaining global licensing process without a hitch."
